NCT02234830

Brief Summary

Is the ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence of adverse access site related events at 30 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
818

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2017

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

3.4 years

First QC Date

June 6, 2014

Last Update Submit

May 31, 2017

Conditions

Coronary Disease

Keywords

PCI

Outcome Measures

Primary Outcomes (1)

  • Incidence at 30 days of the composite endpoint of access site related major adverse vascular events (MAVE)

    This includes: major bleeding and/or bleeding necessitating blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery and/or possible related vascular surgery, infection needing antibiotics.

    30 days

Secondary Outcomes (14)

  • Time to haemostasis from removing the sheath (AngioSeal) or inserting the device (ExoSeal) until haemostasis

    participants will be followed for the duration of hospital stay, an expected average of 2 days

  • Device failure

    30 minutes

  • Vasovagal reaction until 5 minutes after end of closure procedure

    30 minuts

  • Need for new onset of manual compression

    30 days

  • Pain and discomfort related to the closure procedure

    Closure procedure and 30 days

  • +9 more secondary outcomes

Study Arms (2)

Exoseal closure device

EXPERIMENTAL

Closure device for femoral artery access closure

Device: Exoseal closure device

Angio-Seal closure device

ACTIVE COMPARATOR

Closure device for femoral artery access closure

Device: Angioseal closure device

Interventions

Exoseal closure deviceDEVICE

Closure device for femoral artery access closure

Exoseal closure device
Angioseal closure deviceDEVICE

Closure device for femoral artery access closure

Angio-Seal closure device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Should be able to provide valid informed signed consent
  • PCI procedure including treatment by balloon and/or stent
  • PCI indicated by silent ischemia, stable angina pectoris, non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI)

You may not qualify if:

  • Only coronary angiography
  • Multiple punctures
  • Active infection
  • Groin haematoma before the closure procedure
  • Sheath size \> 7 French
  • Known pseudoaneurysm or arteriovenous (AV)-fistula in the ipsilateral groin
  • Prior arterial surgery in abdomen and/or lower extremities
  • Cardiogenic shock
  • Life expectancy less than one year
  • The patient is a female of childbearing potential with possible pregnancy or a positive pregnancy test within 7 days before the index procedure or is lactating
  • Simultaneous or planned subsequent femoral vein access
  • Allergy to any of the components in the closure material left in the groin
  • Puncture on same site \< 30 days
  • Peripheral artery disease patients can be included at operator´s discretion except if heavy calcification is present at the access site which at the operator's discretion precludes insertion of the VCD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Evald H Christiansen, MD, PhD

    Arhus University Hospital Skejby

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 6, 2014

First Posted

September 9, 2014

Study Start

December 21, 2012

Primary Completion

May 14, 2016

Study Completion

May 14, 2017

Last Updated

June 1, 2017

Record last verified: 2017-05

Locations

DK(2)